Treatment of Fecal Incontinence After Obstetric Anal Sphincter Injuries (KISS)

June 20, 2016 updated by: University Hospital of North Norway

A Blinded Randomized Controlled Clinical Trial Comparing Sacral Nerve Modulation and Anal Bulking Injections as Treatment for Fecal Incontinence After Obstetric Anal Sphincter Injuries (OASIS).

Fecal incontinence (FI), the involuntary loss of solid or liquid stool, is a stigmatising condition. It can have a distressing impact and restriction on quality of life. Obstetric-related fecal incontinence may occur early after childbirth. Previous obstetric injury is a major cause of fecal incontinence in older women.

When conservative treatment fails, surgery may be an option. Both sacral nerve modulation and anal bulking injections is minimal invasive surgical alternatives. Step one in SNM is a trial period of temporary stimulation. If the test is successful, the patient can have an implantable stimulator (step 2). Transanal submucosal bulking injection of collagen is also a possible treatment option and can be an effective treatment for faecal incontinence.

The purpose of this study is to compare the efficacy of sacral nerve stimulation to anal bulking injections in women with fecal incontinence after obstetric sphincter injuries (OASIS), through a multicenter blinded, randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstetric anal sphincter injuries (OASIS) is the most common cause of fecal incontinence (FI) in women. Obstetric-related FI may occur early after childbirth. Previous obstetric injury is also a major cause of FI in older women, and risk of FI increases with time and further childbirths. FI is involuntary loss of solid or liquid stool. Symptoms range from fecal urgency, soiling, to daily passive or urge fecal incontinence. FI is a stigmatizing condition. It can have a distressing impact and restriction on quality of life, including isolation and depression.

Tears during delivery is classified (Sultan) as first degree tears including vaginal epithelium, second degree tears into the perineal muscle, third degree involving the anal sphincter complex and fourth degree including sphincter complex and anorectal epithelium. OASIS includes third and fourth degrees tears.

First line of therapy of FI is conservative treatment including drug therapy and "biofeedback". If conservative treatment fails, surgery may be an option. Traditionally elective secondary sphincter repair has been performed at least once. Sphincter repair may improve symptoms in short time, but efficacy deteriorates with time.

Other minimal invasive surgical alternatives includes sacral nerve modulation (SNM) and anal bulking injection. Sacral nerve modulation involves stimulating the sacral nerves, usually S3 or S4. Step one is a trial period of temporary stimulation (PNE test). If the test is successful, the patient can have an implantable stimulator (step 2) to modulate sacral nerve function. SNM is also beneficial for treating FI after OASIS, and SNM is a alternative to secondary sphincter repair. SNM should possibly be preferred second line treatment also after sphincter tears related FI. Transanal submucosal bulking injection of collagen is also a possible treatment option and can be an effective treatment for both anal and fecal incontinence.

The purpose of this study is to compare the efficacy of sacral nerve modulation to anal bulking injections in women with fecal incontinence after OASIS through a Scandinavian multicenter single-blinded, randomized controlled trial.

To answer the research question, we will include 66-86 women with FI after OASIS. Sphincter defects are classified using three dimensional endoanal ultrasonography. Pelvic floor function including FI is registered using validated questionnaires. All women eligible for inclusion is PNE-tested for three weeks. The purpose of this cohort analysis, is to examine the possible effect of SNM in women with sphincter defects, and the hypothesis is that there is no relation between sphincter defect classified using tree dimensional ultrasound and efficacy of SNM.

Women with more than 50 % symptom reduction during PNE test (positive PNE test), is further randomized and allocated 1:1 into one of two arms with 28 participants. One group is allocated to implantation of permanent impulse generator, Interstim II-3058 and the other group is allocated to anal sub mucosal bulking injection of collagen, Permacol. The purpose of this study is to compare the efficacy of SNM to anal bulking injection. The hypothesis is that SNM provides a mean change in improvement in St Marks Incontinence score of more than 4 compared to the anal bulking group. This study is designed as a multicenter single-blinded, randomized controlled trial.

Women with less than 50 % symptom reduction (15-28, negative PNE test), is treated in a third arm with anal bulking injection. The purpose of this cohort study, is to examine the efficacy of anal bulking injection in women suffering from FI after sphincter tears, excluded from further treatment with SNM.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Troms
      • Tromsoe, Troms, Norway, 9037
        • Dep. of Colorectal Surgery, University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • fecal incontinence after OASIS
  • St Marks score > 8
  • failure of conservative treatment

Exclusion Criteria:

  • pregnancy
  • immunosuppressed
  • former major pelvic surgery or irradiation
  • Rectal prolapse
  • complex fistula
  • IBD
  • Lateral sphincterotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sacral nerve modulation
Implantation of Interstim II-3058 impulse generator after positive PNE test. Randomized controlled trial.
Device: Medtronic Interstim II-3058
impulse generator
Active Comparator: anal bulking agents
anal injection with Permacol after positive PNE test. Randomized controlled trial.
Procedure: Anal bulking injection

Permacol injection:

four submucosal injections are administered at the 12, 3, 6 and 9 o'clock positions, above the level of the dentate line. The injection produces a bulge in the mucosa
Active Comparator: Anal bulking agents
Anal injection with Permacol after negative PNE test. cohort study.
Procedure: Anal bulking injection

Permacol injection:

four submucosal injections are administered at the 12, 3, 6 and 9 o'clock positions, above the level of the dentate line. The injection produces a bulge in the mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in St Marks incontinence score
Time Frame: 6 month after treatment
Vaizey Incontinence Score A scale from 0-24 where 0 = perfect continence and 24 = complete incontinence. 3, 6 and 12 months
6 month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in number of fecal incontinence and urgency episodes per week
Time Frame: 3 and 6 month after treatment
3 and 6 month after treatment
change in Quality of life assessment (Rockwood- Fecal incontinence quality of life )
Time Frame: 3 and 6 month
change in FIQL and EQ-5D
3 and 6 month
change in urinary incontinence score (ICIQ-UI SF)
Time Frame: 3 and 6 month
International consultation on incontinence modular questionnaire, ICIQ-UI Short form, A scale from 0-21 where 0 = perfect continence and 20 = complete incontinence.
3 and 6 month
change in sexual function
Time Frame: 3 and 6 months
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Investigators

  • Principal Investigator: Stig Norderval, PHD MD, University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/|1300/REKnord

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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